Associate Director, Quality Assurance

Gilead Sciences is currently seeking an Associate Director QA located in Oceanside, CA. This position will be the site QA head providing quality leadership & is responsible for all aspects of Quality Assurance.

Responsibilities:
- Direct supervision & training of personnel including performance appraisals, promotions, salary administration, staff hiring, mentoring, & other personnel related activities
- Provides CGMP guidance to internal departments for all phases of product development as applicable.
- Develops the plans & implements the actions necessary to ensure that the site operates within the appropriate quality assurance procedures
- Encourages continuous improvements in quality systems & department infrastructure, via creation/revision of appropriate SOPs
- Ensures effective QA support for manufacturing & disposition of bulk drug substance lots
- Oversees validation activities
- Interacts with testing laboratories to resolve issues involved in records or executions
- Provides leadership to prepare for inspections by health agencies as needed
- Assists in regulatory CMC submissions for USA & worldwide heath agencies
- Ensures compliance with quality systems such as change control, SOPs, investigations & Quality Agreements
- Participates & represents QA in sub-team meetings & discussions as needed

Skills:
- Strong working knowledge of CGMP concepts/requirements as it applies to the quality arena in biologics, specifically monoclonal antibodies
- Demonstrates ability to resolve complex problems where analysis of situations or data requires an in-depth evaluation of various factors
- Extensive experience in QA support of Manufacturing automation systems for control of production of bulk drug substance manufacturing is highly desirable
- Excellent verbal, written communication & interpersonal skills
- Superb attention to detail, excellent review skills & the ability to organize & manage multiple tasks in a fast-paced environment

Manages QA personnel, to include organizing & prioritizing group tasks, performing training, & writing performance reviews. Performs a wide variety of activities to ensure compliance with quality systems, quality procedures, quality policies & applicable regulatory requirements to facilitate compliance with regulatory agencies. Develops, implements & maintains programs & processes to ensure high quality products & compliance with Current Good Manufacturing Practices (cGMPs) & Good Laboratory Practices (GLPs) along with compliance of protocols, cGMPs & safety regulations. Approves manufacturing, environmental & laboratory operations, monitoring & quality control data for in-process & finished products. Responsibilities include the final release for all manufactured products. Manages technical complaints & recalls. Works directly with operating entities to ensure that inspections, statistical process control analyses & audits are conducted on a continuing basis as specified to enforce requirements & meet specifications. Reviews & approves training programs regarding all aspects of producing quality products. Conducts & approves investigations & corrective & preventive action (CAPA) recommendations related to manufactured products. Works with corporate Research & Development & Clinical during new product start-ups, & establishes key checkpoints for new products & processes. Leads compliance audits as required. Interfaces with regulatory agencies as required. Writes & implements changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed. Develops budgets & monitors expenditures.